Computerized System Validation Engineer

POSITION SUMMARY:

This position is responsible for providing quality assurance that software used to support MSD manufacturing processes, analytical services, and quality management systems is validated, operated, and decommissioned in compliance with MSD policies and procedures and applicable GxP regulations. The incumbent is expected to lead validation activities for assigned projects and perform a variety of tasks supporting the validation program while working closely within project teams, often under deadlines.

DUTIES AND RESPONSIBILITIES

• Support Computerized System Validation (CSV) activities across various platforms, including Lab Information Management Systems (LIMS), Enterprise Resource Planning (ERP), Automation Programmable Logic Controller (PLC), Building Management Software (BMS), Manufacturing Execution Systems (MES), Product Lifecycle Management (PLM), Quality Management Systems (QMS), File Sharing Software, Calibration and Maintenance Management Systems (CMMS), and custom web applications.
• Ensure compliance to MSD quality management system (QMS) processes and procedures and adherence to 21 CFR Part 11, data integrity principles and Good Laboratory Practice/Good Clinical Laboratory Practice where applicable.
• Provide guidance to QA, IS/IT, and system owners on the elements pertaining to validation, and provide CSV training.
• Provide technical guidance on validation requirements for new and existing software to system owners.
• Author, review, and approve validation deliverables, including Requirements, Design Specifications, Validation Plans, Risk Assessments, Test Protocols, Validation Reports, Traceability Matrices, and Validation Change Orders.
• Execute validation protocols and provide objective evidence that system is compliant to applicable regulations and requirements.
• Review and Approve changes to validated systems:
  
  
  
  • Interact with IS/IT, Quality, supporting departments, system owners and contractors to facilitate or perform validation activities.
  • Document, review, approve, and resolve variances that occur.
  • Compile and analyze submitted validation data for review and approval.
  • Prepare and review completed and executed validation packages
  
  
  
  
• Maintain list of validated computerized systems, related change control documentation, intended use and GxP impact to track software validations and upgrades.
• Conduct periodic reviews to ensure systems are maintained in a validated state during the course of the system operational phase.
• Maintain up-to-date knowledge of validation requirements, best practices, and procedures. Provide pertinent information to senior stakeholders and attend cross-functional team meetings as the subject matter expert.
• Represent and defend validation programs to client auditors and regulatory authorities.
• Specific duties may vary depending upon departmental requirements.

EXPERIENCE AND QUALIFICATIONS

• Bachelor's degree (BS/BA) in Computer Science, Engineering, or related field; equivalent experience may be accepted.
• Minimum of 3 years of experience in computerized systems validation in a relevant industry (e.g., in vitro diagnostics, medical device, biotech, pharmaceutical, regulated bioanalysis).
• Experience with quality management systems compliant to ISO 9001 and ISO 13485 strongly preferred.
• Experience with validating computerized systems in a GLP/GCLP environment strongly preferred.

KNOWLEDGE, SKILLS AND ABILITIES

• Knowledge of working in a regulated environment and standard industry validation practices is required.
• Knowledge of Good Automated Manufacturing Practice (GAMP) guidelines, computerized system validation principles and best practices is required.
• Working knowledge of 21 CFR Part 11 requirements and data integrity principles, including technical and procedural controls.
• Working knowledge of 21 CFR Part 58 (GLP) and Good Clinical Laboratory Practice.
• Ability to interpret regulatory requirements and apply them to system implementation and validation.
• Fundamental understanding of IT infrastructure, including client server architecture, networks, and data backup/restore.
• Experience with both cloud-based and on premise software applications preferred.
• Proficiency in Microsoft Office Suite, Jira, and standard productivity tools; expert in Office and Excel.
• Effective time management and multi-tasking skills - able to keep an eye on the big picture outcome while managing day to day tasks and deadlines to meet key deliverables
• Ability to effectively manage complex projects across multiple departments without direct supervision.
• Ability to work with a high level of detail and to a high standard.
• Strong oral, written communication and interpersonal skills are required; able to clearly and concisely deliver technical information.

PHYSICAL DEMANDS

This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office.

WORK ENVIRONMENT

This is a hybrid position performed in a standard office environment, may additionally be performed in a suitable home office environment, and may spend time in a Low Particulate Room or BSL-1/BSL-2 laboratory environment as needed.

COMPENSATION SUMMARY

The annual base salary for this position ranges from $78,100 to $116,200. This salary range represents a general guideline as MSD considers other factors when presenting an offer of employment, such as scope and responsibilities of the position, external market factors, and the candidate's knowledge, skills, abilities, education and experience. Employees may qualify for a discretionary or non-discretionary bonus in addition to their base salary. These annual bonuses are intended to recognize individual performance and enable employees to benefit from the Company's overall success.

BENEFITS SUMMARY

At MSD, we offer a comprehensive benefits package to support our employees' well-being and financial security. In addition to competitive salaries, our benefits include medical, dental, and vision coverage, along with prescription benefits. We provide a 401(k) plan with company matching, flexible spending accounts, and company-paid short- and long-term disability insurance as well as group life and accidental death and dismemberment insurance. Our offerings also encompass paid vacation, paid sick leave, paid holidays, and paid parental leave, along with an employee assistance program. Additional voluntary perks include a fitness club membership contribution, pet insurance, identity theft protection, home and auto insurance discounts, and optional supplemental life insurance.

EEO STATEMENT

MSD is an Equal Opportunity Employer. We are committed to fostering a diverse and inclusive workplace where all individuals are treated with respect and dignity. We welcome applications from all qualified candidates, making employment decisions without regard to race, color, religion, creed, sex, genetic information, marital status, national origin, age, protected veteran status, pregnancy, disability status, or any other protected characteristic. For our full EEO statement, please visit here. Meso Scale Diagnostics uses E-Verify to validate the work eligibility of candidates.